GMPs

Nov 02, 2017
Pharmaceutical Technology
Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
Oct 31, 2017
By Pharmaceutical Technology Editors
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
Oct 25, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
Oct 23, 2017
By Pharmaceutical Technology Editors
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
Oct 11, 2017
By Pharmaceutical Technology Editors
FDA published guidance on the format and content of REMS documents.
Oct 11, 2017
By Pharmaceutical Technology Editors
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
Oct 11, 2017
By Pharmaceutical Technology Editors
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
Oct 02, 2017
Pharmaceutical Technology
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Oct 02, 2017
Pharmaceutical Technology
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Oct 02, 2017
By Pharmaceutical Technology Editors
The agency published four guidance documents regarding ANDAs and amendments to ANDAs.
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